ID

28492

Beskrivning

The Medtronic RESOLUTE US Clinical Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00726453

Länk

https://clinicaltrials.gov/show/NCT00726453

Nyckelord

Versioner (1)
  1. 2018-01-18 2018-01-18 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

18 januari 2018

DOI

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Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00726453

Engelsk

Eligibility Coronary Artery Disease NCT00726453

1 Formulär  
Criteria
Beskrivning

Criteria

acceptable candidate for percutaneous coronary intervention (pci),stenting, and emergency coronary artery bypass graft surgery
Beskrivning

Patient Appropriate Percutaneous Coronary Intervention | Patient Appropriate Stenting | Patient Appropriate Emergency Coronary Artery Bypass Surgery

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C1532338
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C1548787
UMLS CUI [2,3]
C2348535
UMLS CUI [3,1]
C0030705
UMLS CUI [3,2]
C1548787
UMLS CUI [3,3]
C0013956
UMLS CUI [3,4]
C0010055
clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia and/or positive functional study
Beskrivning

Myocardial Ischemia | Stable angina | Angina, Unstable | Silent myocardial ischemia | Test Functional Positive

Datatyp

boolean

Alias
UMLS CUI [1]
C0151744
UMLS CUI [2]
C0340288
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0340291
UMLS CUI [5,1]
C0039593
UMLS CUI [5,2]
C0205245
UMLS CUI [5,3]
C1514241
informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
patient agrees to comply with specified follow-up evaluations at same investigational site
Beskrivning

Compliance behavior Follow-up Evaluation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1321605
UMLS CUI [1,2]
C3274571
UMLS CUI [1,3]
C1261322
single target lesion or two target lesions located in separate coronary arteries
Beskrivning

Target Lesion Quantity | Location Coronary arteries Separate

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1265611
UMLS CUI [2,1]
C1515974
UMLS CUI [2,2]
C0205042
UMLS CUI [2,3]
C0443299
de novo lesion(s) in native coronary artery(ies)
Beskrivning

Lesion de novo Coronary artery Native

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1515568
UMLS CUI [1,3]
C0205042
UMLS CUI [1,4]
C0302891
target lesion(s) ≤ 27 mm in length (or ≤ 35 mm for a lesion to be treated with a 38 mm length stent)
Beskrivning

Target Lesion Length | Stent Length

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2986546
UMLS CUI [1,2]
C1444754
UMLS CUI [2,1]
C0038257
UMLS CUI [2,2]
C1444754
target vessel(s) have reference vessel diameter 2.25 mm to 4.2 mm, (or 3.0 to 4.2 mm for it to be treated with a 38 mm length stent)
Beskrivning

Target vessel | Reference Vessel Diameter | Stent Length

Datatyp

boolean

Alias
UMLS CUI [1]
C0449618
UMLS CUI [2,1]
C1706462
UMLS CUI [2,2]
C0005847
UMLS CUI [2,3]
C1301886
UMLS CUI [3,1]
C0038257
UMLS CUI [3,2]
C1444754
general and angiographic exclusion criteria highlights:
Beskrivning

Exclusion Criteria General | Exclusion Criteria Angiography

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0205246
UMLS CUI [2,1]
C0680251
UMLS CUI [2,2]
C0002978
within 7 days of implant platelet count <100,000 cells/mm³ or >700,000 cells/mm³; wbc count <3,000 cells/mm³; serum creatinine level >2.5 mg/dl
Beskrivning

Implantation Time period | Platelet Count measurement | White Blood Cell Count procedure | Creatinine measurement, serum

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021107
UMLS CUI [1,2]
C1948053
UMLS CUI [2]
C0032181
UMLS CUI [3]
C0023508
UMLS CUI [4]
C0201976
acute mi within 72 hrs of the index procedure (qwmi or any elevation of ck-mb > lab upper limit of normal)
Beskrivning

Myocardial Infarction | Acute Q wave myocardial infarction | Increased CK-MB

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0582803
UMLS CUI [3]
C1834663
previous pci of target vessel(s) within 9 months prior to the procedure
Beskrivning

Percutaneous Coronary Intervention Previous Target vessel

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C0205156
UMLS CUI [1,3]
C0449618
planned pci of any vessel within 30 days post-index procedure and/or planned pci of target vessel(s) within 12 months post-index procedure
Beskrivning

Percutaneous Coronary Intervention Planned Blood Vessel | Percutaneous Coronary Intervention Planned Target vessel

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C1301732
UMLS CUI [1,3]
C0005847
UMLS CUI [2,1]
C1532338
UMLS CUI [2,2]
C1301732
UMLS CUI [2,3]
C0449618
history of stroke or tia within prior 6 months
Beskrivning

Cerebrovascular accident | Transient Ischemic Attack

Datatyp

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
participating in investigational drug/device study that has not completed primary endpoint or interferes with study endpoints
Beskrivning

Study Subject Participation Status Primary Endpoint Incomplete | Investigational New Drugs | Investigational Medical Device | Study Subject Participation Status Interferes with End Point

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C2986535
UMLS CUI [1,3]
C0205257
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
UMLS CUI [4,1]
C2348568
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C2349179
inability to comply with required trial antiplatelet regimen
Beskrivning

Antiplatelet therapy Compliance behavior Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1096021
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C1299582
previous stent in target vessel unless it has been at least 9 months since stent placed and target lesion(s) is/are at least 15 mm from previous stent
Beskrivning

Previous stent placement Target vessel

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2114504
UMLS CUI [1,2]
C0449618
target vessel(s) has/have other lesions w/ > 40% diameter stenosis
Beskrivning

Target vessel Lesion Percent Diameter Stenosis Measurement

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0449618
UMLS CUI [1,2]
C0221198
UMLS CUI [1,3]
C3897965
unprotected left main coronary artery disease
Beskrivning

Left main coronary artery disease untreated

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1299433
UMLS CUI [1,2]
C0332155
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Similar models

Eligibility Coronary Artery Disease NCT00726453

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
Patient Appropriate Percutaneous Coronary Intervention | Patient Appropriate Stenting | Patient Appropriate Emergency Coronary Artery Bypass Surgery
Item
acceptable candidate for percutaneous coronary intervention (pci),stenting, and emergency coronary artery bypass graft surgery
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C1532338 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C1548787 (UMLS CUI [2,2])
C2348535 (UMLS CUI [2,3])
C0030705 (UMLS CUI [3,1])
C1548787 (UMLS CUI [3,2])
C0013956 (UMLS CUI [3,3])
C0010055 (UMLS CUI [3,4])
Myocardial Ischemia | Stable angina | Angina, Unstable | Silent myocardial ischemia | Test Functional Positive
Item
clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia and/or positive functional study
boolean
C0151744 (UMLS CUI [1])
C0340288 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0340291 (UMLS CUI [4])
C0039593 (UMLS CUI [5,1])
C0205245 (UMLS CUI [5,2])
C1514241 (UMLS CUI [5,3])
Informed Consent
Item
informed consent
boolean
C0021430 (UMLS CUI [1])
Compliance behavior Follow-up Evaluation
Item
patient agrees to comply with specified follow-up evaluations at same investigational site
boolean
C1321605 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,3])
Target Lesion Quantity | Location Coronary arteries Separate
Item
single target lesion or two target lesions located in separate coronary arteries
boolean
C2986546 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C1515974 (UMLS CUI [2,1])
C0205042 (UMLS CUI [2,2])
C0443299 (UMLS CUI [2,3])
Lesion de novo Coronary artery Native
Item
de novo lesion(s) in native coronary artery(ies)
boolean
C0221198 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C0205042 (UMLS CUI [1,3])
C0302891 (UMLS CUI [1,4])
Target Lesion Length | Stent Length
Item
target lesion(s) ≤ 27 mm in length (or ≤ 35 mm for a lesion to be treated with a 38 mm length stent)
boolean
C2986546 (UMLS CUI [1,1])
C1444754 (UMLS CUI [1,2])
C0038257 (UMLS CUI [2,1])
C1444754 (UMLS CUI [2,2])
Target vessel | Reference Vessel Diameter | Stent Length
Item
target vessel(s) have reference vessel diameter 2.25 mm to 4.2 mm, (or 3.0 to 4.2 mm for it to be treated with a 38 mm length stent)
boolean
C0449618 (UMLS CUI [1])
C1706462 (UMLS CUI [2,1])
C0005847 (UMLS CUI [2,2])
C1301886 (UMLS CUI [2,3])
C0038257 (UMLS CUI [3,1])
C1444754 (UMLS CUI [3,2])
Exclusion Criteria General | Exclusion Criteria Angiography
Item
general and angiographic exclusion criteria highlights:
boolean
C0680251 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
C0680251 (UMLS CUI [2,1])
C0002978 (UMLS CUI [2,2])
Implantation Time period | Platelet Count measurement | White Blood Cell Count procedure | Creatinine measurement, serum
Item
within 7 days of implant platelet count <100,000 cells/mm³ or >700,000 cells/mm³; wbc count <3,000 cells/mm³; serum creatinine level >2.5 mg/dl
boolean
C0021107 (UMLS CUI [1,1])
C1948053 (UMLS CUI [1,2])
C0032181 (UMLS CUI [2])
C0023508 (UMLS CUI [3])
C0201976 (UMLS CUI [4])
Myocardial Infarction | Acute Q wave myocardial infarction | Increased CK-MB
Item
acute mi within 72 hrs of the index procedure (qwmi or any elevation of ck-mb > lab upper limit of normal)
boolean
C0027051 (UMLS CUI [1])
C0582803 (UMLS CUI [2])
C1834663 (UMLS CUI [3])
Percutaneous Coronary Intervention Previous Target vessel
Item
previous pci of target vessel(s) within 9 months prior to the procedure
boolean
C1532338 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0449618 (UMLS CUI [1,3])
Percutaneous Coronary Intervention Planned Blood Vessel | Percutaneous Coronary Intervention Planned Target vessel
Item
planned pci of any vessel within 30 days post-index procedure and/or planned pci of target vessel(s) within 12 months post-index procedure
boolean
C1532338 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0005847 (UMLS CUI [1,3])
C1532338 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0449618 (UMLS CUI [2,3])
Cerebrovascular accident | Transient Ischemic Attack
Item
history of stroke or tia within prior 6 months
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Study Subject Participation Status Primary Endpoint Incomplete | Investigational New Drugs | Investigational Medical Device | Study Subject Participation Status Interferes with End Point
Item
participating in investigational drug/device study that has not completed primary endpoint or interferes with study endpoints
boolean
C2348568 (UMLS CUI [1,1])
C2986535 (UMLS CUI [1,2])
C0205257 (UMLS CUI [1,3])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
C2348568 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C2349179 (UMLS CUI [4,3])
Antiplatelet therapy Compliance behavior Unable
Item
inability to comply with required trial antiplatelet regimen
boolean
C1096021 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Previous stent placement Target vessel
Item
previous stent in target vessel unless it has been at least 9 months since stent placed and target lesion(s) is/are at least 15 mm from previous stent
boolean
C2114504 (UMLS CUI [1,1])
C0449618 (UMLS CUI [1,2])
Target vessel Lesion Percent Diameter Stenosis Measurement
Item
target vessel(s) has/have other lesions w/ > 40% diameter stenosis
boolean
C0449618 (UMLS CUI [1,1])
C0221198 (UMLS CUI [1,2])
C3897965 (UMLS CUI [1,3])
Left main coronary artery disease untreated
Item
unprotected left main coronary artery disease
boolean
C1299433 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
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